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Senior Scientific Writer

Hyderabad, India Permanent Posted on   Nov. 29, 2024 Closing on   May. 27, 2025
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  • Main responsibilities:

    Management of Quality Systems

    • Compilation, Review & Management of overall Product Quality Reviews system.
    • Act as site coordinator for change controls & management of change control system.
    • Management of Deviation system.
    • Management of Market complaint investigation system.
    • Act as QA focal point for OOS/OOT management.
    • Management of Training system.
    • Oversight on Pest Control system.
    • To perform Nitrosamine Assessment & review.
    • Management of ICHQ3D requirements.
    • Site coordinaator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)
    • Act as focal point for Subcontractors/ Service Providers management.
    • Management of overall Validation systems (Process, cleaning, transport & computerized system)
    • Management of CAPA System.

    Quality Management Systems

    • Coordinating for conducting self-inspection as per planner and associated self-inspection activities.
    • Review and Approval of GxP documents, batch manufacturing record and batch packing record in electronic-document system.
    • Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc.
    • Coordination of cGMP training activity including training of the people & review of training module.
    • Initiation, implementation, and closure of change controls.
    • Initiation of deviation and support in deviation investigation.
    • Support in Market Complaint investigation.
    • Implementation of assigned CAPAs and support in closure.
    • Implementation of assigned Efficiency Reviews (ERs).
    • Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned.
    • Batch release & response to queries from QP.
    • Management of Data integrity aspects.
    • Participation and support in SMS initiatives. 
    • Support for HSE activities.
    • Handling of Site Master File (SMF).
    • Calibration document review of Engineering/QC/PMTD.
    • User access management & review
    • Analytical method creation
    • Audit trail review
    • Document archival/retrieval management.

    Validation & Qualifications

    • Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
    • Quality focal point for temperature/ relative humidity mapping activities.
    • Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length.
    • Quality focal point for utilities & purified water system.
    • Management of Site Qualification & Validation Master Plan       

    In-Process Quality Assurance [IPQA]

    • Review & Approval of Master Batch Records & executed Batch Records
    • Review and Approval of logbooks.
    • Line clearance in Production.
    • To perform In-process checks in Production.
    • Sampling of products during routine production and validation.
    • Quality oversight on shopfloor.

    HSE

    • Adherence to all health safety & environmental aspects as required by company policies and procedures.
    • Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
    • Conducting daily training in the +QDCI meeting address any unsafe condition.
    • Take suggestion from associates to improve the work conditions with great safety and zero risk.
    • Periodic review of the implemented procedures and evaluation of the same.
    • Train people on safety and their job to ensure zero LTI and IWLT at workplace.

    Languages: English, Hindi, Konkani, Marathi

    • Qualification: B.Pharm / M.Pharm

    Experience-3-5 years experience

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